DESTINY-Breast01: Patients Demographics and Baseline Characteristics
Patients Treated by Region1
Patients Treated by Region1
Patients Treated by Region1
Patient Disposition1-4
Patient Disposition.1-4
Patient Disposition.1-4
aOf the 100 patients who were excluded from participating in the study, 94 either did not meet the criteria for inclusion or met the criteria for exclusion, 2 withdrew consent, 1 was receiving long-term glucocorticoid therapy for fibromyalgia, 1 had new intracranial metastatic lesions, 1 was lost to follow-up, and 1 missed the deadline for reconsent.
Baseline Characteristics1,3
Patients who received 5.4 mg/kg (n=184) | All Patients (N=253) | |
| Age, median (range), yearsa | 55.0 (28-96) | 56.0 (28.0-96.0) |
| ≥65 years, n (%) | 44 (23.9) | 64 (25.3) |
| Female, n (%) | 184 (100) | 253 (100) |
| Race, n (%)b | ||
| Asian | 70 (38.0) | 104 (41.1) |
| White | 101 (54.9) | 132 (52.2) |
| Other | 9 (4.9) | 12 (4.7) |
| Missing | 4 (2.2) | 5 (2.0) |
| Region, n (%) | ||
| Europe | 68 (37.0) | 80 (31.6) |
| Asia | 63 (34.2) | 96 (37.9) |
| North America | 53 (28.8) | 77 (30.4) |
| ECOG PS, n (%)c | ||
| 0 | 102 (55.4) | 146 (57.7) |
| 1 | 81 (44.0) | 106 (41.9) |
| 2 | 1 (0.5) | 1 (0.4) |
| Hormone receptor status, n (%) | ||
| Positive | 97 (52.7) | 127 (50.2) |
| Negative | 83 (45.1) | 122 (48.2) |
| Unknown | 4 (2.2) | 4 (1.6) |
| HER2 expression, n (%)d | ||
| IHC 3+ | 154 (83.7) | 213 (84.2) |
| IHC 1+ or 2+, ISH+ | 28 (15.2) | 38 (15.0) |
| Missing datae | 2 (1.1) | 2 (0.8) |
| Sum of diameters of target lesions (centimeter), median (range) | 5.5 (1.2-24.5) | 5.40 (1.1-24.5) |
| No. of prior cancer therapy regimens, median (range) | 6 (2-27) | 6 (2-27) |
| Prior cancer systemic therapy, n (%) | ||
| Trastuzumab | 184 (100) | 253 (100) |
| T-DM1f | 184 (100) | 253 (100) |
| Pertuzumab | 121 (65.8) | 175 (69.2) |
| Other anti-HER2 antibodies or ADCs | 11 (6.0) | 14 (5.5) |
| HER2 tyrosine kinase inhibitors | 93 (50.5) | 121 (47.8) |
| Hormone therapy | 90 (48.9) | 119 (47.0) |
| Other systemic therapy | 183 (99.5) | 252 (99.6) |
| Best response to T-DM1 therapy, n (%) | ||
| Complete response/partial response/ stable disease | 79 (42.9) | 110 (43.5) |
| Progressive disease | 66 (35.9) | 99 (39.1) |
| Not evaluable | 39 (21.2) | 44 (17.4) |
Note: Percentages may not total 100 because of rounding
aMedian age at informed consent; bRace was reported by the patients; cPS scores on the ECOG scale range from 0 (no disability) to 5 (death); dHER2 expression was centrally confirmed by analysis of the most recent archival tissue, according to the guidelines of the American Society of Clinical Oncology–College of American Pathologists. HER2 positivity was defined as HER2 IHC score of 1+ or 2+ and positive results on in situ hybridization (ISH), or IHC 3+ (positive). Data for patients with IHC score indicated as 1+ or 2+ include data for patients for whom the result was equivocal or could not be evaluated; eOne patient sample was IHC 2+, ISH equivocal. One patient had a sample from June 2018 that was IHC 2+ and ISH not evaluable but was enrolled based on a central laboratory IHC 3+ sample from September 2017; fA total of 56 patients (30.4%) received T-DXd immediately after initial therapy with T-DM1.
Abbreviations
ADC = antibody-drug conjugate
;DCO = data cut-off
;ECOG = Eastern Cooperative Oncology Group
;HER2 = human epidermal growth factor receptor 2
;IHC = immunohistochemistry
;ISH = in situ hybridization
;ORR = objective response rate
;PFS = progression-free survival
;PS = performance status
;RP2D = recommended phase 2 dose
;T-DM1 = trastuzumab emtansine
;T-DXd = trastuzumab deruxtecan
;TEAE = treatment emergent adverse event
References
2. Modi S, Saura C, Yamashita T, et al. Updated results from DESTINY-Breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd) in HER2-positive metastatic breast cancer [poster and abstract]. Poster presented at: San Antonio Breast Cancer Symposium; December 8-11, 2020. Cancer Res. 2021;81(suppl 4). Abstract PD3-06.
3. Saura C, Modi S, Krop I, et al. Trastuzumab Deruxtecan (T-DXd) in patients with HER2-positive metastatic breast cancer: updated survival results from a phase 2 trial (DESTINY-Breast01) [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) 2021 Annual Meeting; September 16-21, 2021. Ann Oncol. 2021;32(suppl 5). Abstract 279P.
4. Data on file. Daiichi Sankyo, Inc., Basking Ridge, NJ.
5. Tamura K, Modi S, Tsurutani J, et al. Dose justification for DS-8201a, a HER2-targeted antibody-drug conjugate, for HER2-positive breast cancer: Observed clinical data and exposure-response analyses [poster and abstract]. Poster presented at: San Antonio Breast Cancer Symposium; December 4-8, 2018. Cancer Res. 2019;79(suppl 4). Abs P6-17-10.
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